Soaptronic LLC – FDA Inspection, Apr 28, 2010

Record Details

This FDA Inspection record concerns Soaptronic LLC, with an inspection on April 28, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.

Company: Soaptronic LLC
Inspection Date: April 28, 2010
Product Type: Drugs
Office: Center for Drug Evaluation and Research

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ID · d187e69a-fc04-434c-9353-a8247c7cdcc4

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number: 658968
FDA center: Human Drugs
Project area: Drug Quality Assurance

FDA Citations

21 CFR 211.105(a)Identification of containers, lines, equipment
21 CFR 211.188Prepared for each batch, include complete information
21 CFR 211.110(a)Control procedures to monitor and validate performance
21 CFR 211.25(a)Training--operations, GMPs, written procedures
21 CFR 211.25(a)Training , Education , Experience overall
21 CFR 211.63Equipment Design, Size and Location
21 CFR 211.160(b)Scientifically sound laboratory controls
21 CFR 211.160(b)(4)Establishment of calibration procedures
21 CFR 211.198(a)Procedures to be written and followed
21 CFR 211.22(a)Lack of quality control unit

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Other FDA inspections of Soaptronic LLC

Date	Classification	Office	Project area
April 28, 2025	VAI	Los Angeles District Office	Drug Quality Assurance
February 14, 2020	VAI	Center for Drug Evaluation and Research	Drug Quality Assurance
June 23, 2016	VAI	Center for Drug Evaluation and Research	Drug Quality Assurance
October 21, 2011	VAI	Center for Drug Evaluation and Research	Drug Quality Assurance
December 16, 2010	VAI	Center for Drug Evaluation and Research	Drug Quality Assurance